Itraconazole pulse therapy vs continuous terbinafine dosing for toenail onychomycosis.

In this open, randomized, parallel-group, the efficacy and safety of itraconazole pulse therapy (1 week 400 mg daily, 3 months) was evaluated in comparison with continuous terbinafine dosing (250 mg daily, 3 months) for the treatment of toenail onychomycosis. The study included a total of 51 patients with distal subungual onychomycosis of the toenails confirmed by microscopy and positive culture. Twenty-six patients received itraconazole pulse therapy and 25 patients received continuous terbinafine therapy. A minimum of 50% nail involvement was a requirement for inclusion. In total, 153 nails (121 toenails) were treated with itraconazole pulse therapy and 162 nails (122 toenails) were treated with continuous terbinafine therapy. Patients were evaluated every third month for 9 months after treatment. Photographs were taken at each visit. Clinical success and mycologic cure (negative potassium hydroxide preparation and culture) were the main outcome measures. Mycologic cure rates were 75% in the itraconazole pulse group and 76% in the continuous terbinafine group at month 12; the corresponding clinical response rates were 77% and 68%, respectively. Six (23%) patients in the itraconazole group reported 7 adverse events and 13 (52%) patients in the terbinafine group reported 19 adverse events. In the terbinafine group, 12% discontinued therapy due to adverse events; no patients in the itraconazole arm discontinued. Both therapies showed comparable efficacy, though baseline nail severity was greater in the itraconazole group, and adverse effects were greater in the terbinafine group.

RCT Entities:   Population Interventions Outcomes